Tuesday, May 12, 2009

Abilify and the Great Akathisia Cover-up, Part 2

Yesterday, I described a patient who experienced transient severe jitteriness and shakiness on Abilify 5 mg/day. She did not want to discontinue it yet, and as I mentioned, I'll provide an update when I see her next.

Today, I saw a woman in her 30s who has suffered recurrent depression and anxiety for years. I had recently added Wellbutrin SR to her Effexor XR and Klonopin. This seemed to help decrease her crying jags initially, but after a few months she became depressed and hopeless again. She was seeing her therapist regularly, but that wasn't doing the trick. So at her last visit in March, I had her discontinue the Wellbutrin and I added Abilify at 10 mg a day. Today, she said that she stopped the Abilify after 2 weeks, because "I felt like I was having 10 cups of coffee per day." She couldn't sleep, despite taking Ambien 10 mg at night.

Nonetheless, she feels less depressed today because over the couple of months since she stopped the Abilify, she began seeing her therapist more often, up to twice a week. She feels she has more perspective on some of her stressors (an ill father, financial difficulties).

She's doing okay, but this is another case in which the much vaunted Abilify fails as a augmentation for depression, and reveals its true colors as the antipsychotic most likely to cause akathisia. Clearly, starting her at 10 mg was a mistake, and when I use it in the future, I will start at the lowest possible dose, which is 2 mg.

Meanwhile, BMS is funding plenty of CME about using antipsychotics in depression and is making sure to contract with education companies that will hire key opinion leaders who can be depended upon to go easy on Abilify's side effects. For example, here is how Abilify's side effects are discussed by a noted academic in this online symposiumcreated by CME, LLC:

"Adverse event dropouts; you always want to know, How well were these drugs tolerated? And in this first study it was pretty darned good. I mean, it looked very placebo-like in terms of ability to stay on the drug. The data for both studies when they’re put together in the package insert have a dropout rate of about 6% for aripiprazole. So it’s a bit higher than placebo. A lot of restlessness, a lot of akathisia, you know, people sort of a little bit unable to sort of stay still, but they could tolerate the drug. That’s 23%, 25% in the package insert. So some side effects, but overall pretty good tolerability."

Hmmm...."sort of a little bit unable to sort of stay still, but they could tolerate the drug." This is the beauty of industry-funded CME. You're not buying outright deception and therefore a public relations disaster, but you are buying someone who will handle your product's liabilities with kid gloves.

13 comments:

therapyfirst
said...

Forget about medications for a moment, and think about this instead: maybe a sizeable majority of this "treatment resistance depression" population is because these are people with comorbid Axis II disorders/major characterological features, if not just plain axis II with the mood lability features that are not bipolar or MDD, and so meds are not going to have any real impact.

Am I the only doc, at least who comments at this and other mental health blog sites, who seems to remember there are axis II issues to the diagnostic process? And, when did we as a profession agree to allow non-clinicians dictate what we define are the major factors to the illnesses that present in our offices?

You want to see an end to pharma having too strong an influence to CMEs and treatment choices in general. Take a damn stand and treat the patient in front of you for what the problems are, and stop trying to fit the proverbial square pegs in the round holes!

Oh yeah, by the way, my advice to anyone interested, is always start with the low doses of meds in most patients, if not all until proven otherwise, so you can minimize side effects like akathisia. I'll give BM a little credit, at least they sample the 2mg doses; why Lilly does not give 20mg of Cymbalta out, why Janssen never gave out 2mg of Invega, or AZ stopped sampling 25mg of Seroquel is fairly obvious they wanted to direct prescribing for higher doses.

Shameful? Downright wrong, if not a tinge of evil!

If you, Dr C, are going to the APA next week, good luck looking these alleged colleagues in the face. Soulless beings for doing the things they do. I would hope you would take note of how much pharma has still pervaded the convention.

Forget about Axis II disorders for a minute, and think about this instead: Maybe a sizeable majority of these "treatment resistance depression" and "personality disorders" populations are people with ADHD,

I very much agree with TF that Axis II is frequently overlooked in the rush to medicate. Ironically, my sole success using Abilify for depression occurred recently in a patient who is not clinically depressed (i.e., MDD) at all, but character disordered. Of course, severe character pathology has been treated with low-dose neuroleptics for decades, so this isn't new. Abilify may well be helping depressed people out there, just not always in the way clinicians think it does.

While I support Dan Carlat and all other psychiatrists who try anything reasonable to help their patients, I must say that for garden-variety major depression I personally put a lot of other treatment options ahead of expensive, risky medications like Abilify or Seroquel.

The problem here is not Abilify's presence as an extra tool in the toolbox, but in having it promoted to professionals and the public as a common hammer or screwdriver, when it's really an esoteric tool that's good to have on the rare occasions you really need it.

I agree with Dr Reidbord's comment about some use of antipsychotics for certain presentations of Axis II features, but, low doses. It is ironic that I had some success with Seroquel for Borderline-type issues, but now I am a bit leery to use it of late with the abuse potential issues out there.

Regarding Abilify, I personally think there are more EPS responses with characterological patients, so I do not think of it much, as the last thing I want to see is agitation from meds with agitated people.

By the way, why is it I hear so many colleagues dismiss therapy as part of the intervention for these treatment resistant cases? Just the other day I had a patient admit she is having an affair for a year, and tells me this 6 months into treatment. Now she is taking therapy more seriously and seems to be showing a positive response. Is it me, or didn't I learn that when patients develop chronic illnesses, sometimes it coarsens personality, so wouldn't some therapy be applied to loosen up the resistance/hopelessness that can become entrenched from dealing with said illness?

Re Ms Pera's above comment, I will be frank in saying that if a commenter's observation you are involved in CHADD is true, it is a shame you could not have been forward in noting this involvement, so instead, I am still suspicious of your agenda in promoting ADD issues. That said, yes, ADD could be a substitute diagnosis for treatment resistant mood disorder issues, I have made it, and been successful with stimulant meds where it applies.

Let's be candid here for the other readers, Ms Pera and Dr Carlat, who I hope will print this comment which I feel is not harsh to warrant moderating to not post. When you have an affiliation with a group, again if the comment is true re CHADD, why not put it out there and give your take, so readers will at least know where you stand? I don't trust you and find your rebuttals to have an air of rudeness as much as mine have.

So, hopefully the people who cross your path will do well from your philosophies and recommendations, and hopefully so will those who cross mine for clinical needs. Have a nice day, have a nice life.

Either you have a very short memory or a very selective perception. Or else you're just a sadist.

I long ago, at your request, politely (though your rudeness did not deserve it) laid out all my qualifications, work background, and "agenda": helping people, with no profit agenda. I MAKE NO MONEY. Analyze that! Project on that! Transfer that!

And, for the record, my "affiliation" with CHADD is as a VOLUNTEER. Gasp! Shocking! (You should try it sometime. You know, giving back instead of dishing it out.)

And I'm damn proud to do so because our mental healthcare system is sick, people are dropping through the cracks, and some therapists and psychiatrists would rather stay ignorant and arrogant than expand their skills, not to mention their capacity for empathy. Fortunately, the smart, compassionate ones are learning, but not fast enough to meet the need. And, unfortunately, they don't have time to kibbitz on the Internet.

CHADD, through its national network of VOLUNTEERS, helps thousands of people annually who have nowhere else to turn. And they offer evidence-based strategies. If you ever came to a CHADD conference, you might learn something. You might even find yourself offering more optimistic prognoses to your alleged patients. You're welcome to attend a local meeting, too. But don't expect VIP treatment. We operate on a shoestring.

The reason I never mentioned that I volunteered for CHADD is because that is a conflict of interest, and I take professional ethics seriously. Because I have written a book, that is the focus of most of my online presence. I would not use my volunteer work to publicize the book -- or to let whatever I say reflect badly on CHADD.

But now that you have wrong-headedly attempted to use it as a cudgel, I explain, not to you but to those who are genuinely interested in this fine non-profit that truly does save many lives every day.

Please do print this out, for the next time you feel like ordering me to "be candid." I'm not going to repeat it. Perhaps some day you will reveal yourself, as if you haven't by your words.

I am a patient of a psychiatrist I have trusted for years. After reading your blogs, it makes me wonder whether the Dr.'s need therapy! You seem to spend more time demeaning each other than you do actually thinking about your patients. Debate is good, but respect for each other is more important. As these drugs are new, know one knows the exact correct procedure. It's all case by case, trial and error. What works for one, may not work for another.

As one who depends on your expertise, please focus on what really matters and not on your own egos!

As an EMT, I'd like to mention that I've seen Abilify side effects more than once-- these people tend to think they're having seizures, which really isn't unreasonable when they start having involuntary muscle movements.

As someone who lived with untreated ADD for a long, long time, I'd like to point out that it can look an awful lot like not only treatment-resistant depression, but PTSD as well -- you try going your whole life not being able to focus, not doing anything as well as you should be, being the geek who isn't even smart, wanting to at least be able to distract yourself from that torture with a good book, but not even being able to focus on that, and see if you don't develop serious problems as a result! It's a traumatic way to live.

HI, ejoyed the post on Abilify. Pardon grammer but i have an injured hand so writing is slow. My son (and I) sure have a story about Abilify. If you ever have time maybe you would like to read my article in my blog titled, "Dear God What is right?" I tried it at 2mg for depression for one day. Tried again at later date 5mg-- for one day! Was enough for me. I shook got sleepy but couldn't sleep, not fun. My son has a much different story. It makes him restless I think and he seems to do things without thinking on it first when he takes it. I don't like that about it. Well, this looks like a good blog. I will come back to visit.

Psych Central referred to this blog in current issue on Abilify (Jan '11). Call me a walking anecdote but I had negligible side effects from augmentation with abilify (for a week I'd wake up at 4, wide awake, then drop off to sleep) and a tremendous result. I mean lucidity soon after starting. Meds are always, when not an outright crapshoot, a serious trade-off: major depression versus lucidity at a price. Rock and hard place, no?